Therapeutic Intervention Effects of rTMS on Children With Autism Spectrum Disorder

Sponsor
University of Electronic Science and Technology of China (Other)
Overall Status
Recruiting
CT.gov ID
NCT05140356
Collaborator
(none)
60
1
3
67.1
0.9

Study Details

Study Description

Brief Summary

Autism spectrum disorder (ASD) is a common and complex neurodevelopmental disorder, which is characterized by impairments of social communication, social reciprocity, as well as restricted and repetitive behaviors (RRB). The unclear pathogenesis of ASD, its increasing prevalence, and its poor clinical diagnosis and treatment effect have caused a serious economic and mental burden on patients and their families. As a new non-invasive neuroelectrophysiological technique, transcranial magnetic stimulation (TMS) has been used more and more in the interventional treatment of autism. The current project aims to explore the influence of TMS on brain plasticity in autism by using TMS for interventional treatment of autism and provide guidelines for the intervention and treatment of autism by evaluating the efficiency of these methods.

Condition or Disease Intervention/Treatment Phase
  • Device: Applied high amplitude repeated transcranial magnetic stimulation
  • Device: Applied low amplitude repeated transcranial magnetic stimulation
N/A

Detailed Description

Autism spectrum disorder (ASD) is a common and complex neurodevelopmental disorder, which is characterized by impairments of social communication, social reciprocity, as well as restricted and repetitive behaviors (RRB). The unclear pathogenesis of ASD, its increasing prevalence, and its poor clinical diagnosis and treatment effect have caused a serious economic and mental burden on patients and their families. As a new non-invasive neuroelectrophysiological technique, transcranial magnetic stimulation (TMS) has been used more and more in the interventional treatment of autism. The current project aims to explore the influence of TMS on brain plasticity in autism by using TMS for interventional treatment of autism and provide guidelines for the intervention and treatment of autism by evaluating the efficiency of these methods. Investigators conduct a randomized, double-blind, controlled TMS trial and collect the participants' stool samples and sequence the gut microbiome before the first magnetic resonance imaging(MRI) scan. Besides, investigators collect brain imaging data, eye movement data and clinical scale score before and after TMS trial to explore the changes of TMS treatment on clinical behavior and brain plasticity and provide guidelines for the intervention and treatment of autism.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
Effects of Repetitive Transcranial Magnetic Stimulation (rTMS) on Neural Mechanisms and Cognitive Functions of Children With Autism Spectrum Disorder
Actual Study Start Date :
May 1, 2019
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: High amplitude repeated transcranial magnetic stimulation

Applied high amplitude repeated transcranial magnetic stimulation

Device: Applied high amplitude repeated transcranial magnetic stimulation
Each mode required 20 stimuli(100%RMT) for 20 minutes each time, 5 times a week

Experimental: Low amplitude repeated transcranial magnetic stimulation

Applied low amplitude repeated transcranial magnetic stimulation

Device: Applied low amplitude repeated transcranial magnetic stimulation
Each mode required 20 stimuli(15%RMT) for 20 minutes each time, 5 times a week

No Intervention: healthy control group

No intervention

Outcome Measures

Primary Outcome Measures

  1. The gray matter volume of children with autism at baseline and after repeated transcranial magnetic stimulation intervention as assessed by magnetic resonance imaging. [through study completion, an average of 1 year]

    Longitudinal study of the gray matter volume will be conducted in children with autism at baseline and after repeated transcranial magnetic stimulation intervention based on structural magnetic resonance image. Longitudinal effect of repeated transcranial magnetic stimulation intervention on brain structure in children with autism will be assessed by Voxel-based morphometry analysis for gray matter volume changes.

Secondary Outcome Measures

  1. The functional connectivity of whole brain of whole brain in children with autism with repeated transcranial magnetic stimulation intervention as assessed by functional magnetic resonance imaging. [through study completion, an average of 1 year]

    Longitudinal study of the functional connectivity will be conducted in children with autism at baseline and after repeated transcranial magnetic stimulation intervention based on resting-state functional magnetic resonance image

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years to 8 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Age range from 2 to 8 years old. Clinical DSM-IV diagnosis of autism.
Exclusion Criteria:
  • Subjects with other neurodevelopmental diseases Subjects with contraindications to MRI.

Contacts and Locations

Locations

Site City State Country Postal Code
1 School of Life Science and Technology, University of Electronic Science and Technology Chengdu Sichuan China 610054

Sponsors and Collaborators

  • University of Electronic Science and Technology of China

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Huafu Chen, professor, University of Electronic Science and Technology of China
ClinicalTrials.gov Identifier:
NCT05140356
Other Study ID Numbers:
  • UESTC-chenhuafulab-003
First Posted:
Dec 1, 2021
Last Update Posted:
Dec 1, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Huafu Chen, professor, University of Electronic Science and Technology of China
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 1, 2021